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Extractables and leachables research is now an important part of the product's release, especially for specialty products such as pharmaceuticals and food. The FDA has indicated that "drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality or purity of the drug beyond the official or established requirements"1. In general, the study of extractables and leachables in packaging mainly involves preparation of the samples and detection of extractables and leachables using different methods. The extractables and leachables are mainly divided into three categories for research.
There is currently no single method to detect all extractables and leachables, and the testing process is complex and multi-layered. In view of the important role of extractables and leachables in the product development process, Alfa Chemistry's team of experts provides global clients with a comprehensive analytical approach to support quantitative and qualitative analysis of extractables and leachables, providing detailed technical reports to ensure the quality of your products. If you have any questions about extractables and leachables analysis, please feel free to contact us.
Common processes for extractables and leachables analysis
Alfa Chemistry's expertise:
Method development and validation of extractables and leachables research.
Label migration study.
Extractables and extractables assessment.
Toxicological evaluation of the extractables detected to determine the target leachables.
Customized testing services, following various regulations for extractables and leachables, such as USP 1663, ISO 10993, ICH Q2 (R1).
Alfa Chemistry's technology platforms include but not limited to: